FDA 510(k)

傷口治療系統（VHT-200）

K 號：K250188 · 2025-03-10

決定日期2025-03-10

產品代碼KPJ

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Wound Treatment System (VHT-200) is the device name listed in this FDA 510(k) record. The listed applicant is Vaporox, Inc.. It received FDA 510(k) clearance on 2025-03-10 under 510(k) number K250188. The device is classified under product code KPJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Wound Treatment System (VHT-200)?

Wound Treatment System (VHT-200) is a medical device that received FDA 510(k) clearance on 2025-03-10. The listed applicant is Vaporox, Inc.. The 510(k) number is K250188.

When did Wound Treatment System (VHT-200) receive FDA 510(k) clearance?

Wound Treatment System (VHT-200) received FDA 510(k) clearance on 2025-03-10, under 510(k) number K250188.

Who is the listed applicant for Wound Treatment System (VHT-200)?

The FDA 510(k) record lists Vaporox, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wound Treatment System (VHT-200)?

The FDA product code for Wound Treatment System (VHT-200) is KPJ.

其他以 Vaporox, Inc. 為申請人之記錄

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K212121VHT-200 點膚治療系統

相關器械（代碼：KPJ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K212121VHT-200 點膚治療系統Vaporox, Inc.K190742EPIFLO-28Neogenix, LLC Dba Ogenix

官方來源

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